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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K133997
FOIA Releasable 510(k) K133997
Device Name LG SMARTHEALTH
Applicant
Lg Electronics
816 Congress Ave. #1400
Austin,  TX  78701
Applicant Contact DIANE SUDDUTH
Correspondent
Lg Electronics
816 Congress Ave. #1400
Austin,  TX  78701
Correspondent Contact DIANE SUDDUTH
Regulation Number870.2910
Classification Product Code
DRG  
Date Received12/27/2013
Decision Date 11/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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